[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Glostrup University Hospital, Copenhagen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,78,106,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100626987","intervention-to-support-partners-and-informal-caregivers-of-frail-ra-patients-100626987",false,"NCT07442773","Intervention to Support Partners and Informal Caregivers of Frail RA-patients","Protocol for the Feasibility Study of INSPIRE: an Individually Tailored Support Intervention for Informal Caregivers of Older Adults With Rheumatoid Arthritis and Frailty","INSPIRE","Inclusion Criteria (Caregivers):\n\n* Informal (unpaid) caregiver of an older adult with confirmed rheumatoid arthritis (RA)\n* Aged ≥ 18 years\n* Care recipient aged ≥ 65 years\n* Able to provide informed consent\n* Able to complete study questionnaires\n* Reports at least moderate caregiver burden, defined as mean CBS score \\> 1.99 at screening (Caregiver Burden Scale)\n\nInclusion Criteria (Care Recipients):\n\n* Aged ≥ 65 years\n* Confirmed diagnosis of RA\n* Meets frailty eligibility in routine care, defined as Clinical Frailty Scale (CFS) ≥ 5\n\nExclusion Criteria (Caregivers):\n\n* Severe cognitive impairment preventing participation\n* Acute mental health crisis\n* Other circumstances making it impracticable to complete the intervention and follow-up assessments","ALL","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with pain, fatigue, functional limitations, and reduced quality of life. As more people live to older age with RA, age-related vulnerability such as frailty becomes increasingly relevant and may amplify functional decline, multimorbidity, and reliance on others. Informal caregivers (unpaid family members, friends, or neighbors) often provide substantial practical, emotional, and coordination support, yet caregiver needs are frequently overlooked in rheumatology care. INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) is an individually tailored support intervention developed using the UK Medical Research Council framework for complex interventions and an iterative co-creation process involving older adults with RA and frailty, caregivers, healthcare professionals, and social care stakeholders. Before a definitive evaluation, feasibility and acceptability in routine care must be established.\n\nAim To evaluate the feasibility and acceptability of delivering INSPIRE in routine rheumatology care and to test study procedures in preparation for a future definitive trial.\n\nMethods This is a single-arm feasibility study recruiting 25 informal caregivers of older adults with RA and frailty. Recruitment will occur within a fixed four-month window (1 March-1 July 2026) and will not be extended. Care recipients (older adults) will be ≥65 years with RA and frailty classified as Clinical Frailty Scale (CFS) 4-7. Caregivers will be ≥18 years, provide unpaid support, and report at least moderate burden defined as a Caregiver Burden Scale (CBS) mean score \\>1.99 at screening. Participants will be recruited from Rigshospitalet (Center for Rheumatology and Spine Diseases) and rheumatology departments in Køge, Slagelse, and Holbæk. Identification uses routine patient-reported outcomes (DANBIO) with invitation of potentially frail patients (e.g., MDHAQ \\>1.0) followed by telephone screening and CFS assessment; eligible patients nominate a caregiver who is then screened using CBS.\n\nIntervention INSPIRE is delivered by a trained healthcare professional over \\~12 weeks and comprises three contacts: an initial consultation (60-90 min), a brief follow-up (15-30 min), and a final consultation (30-60 min). Content is tailored using a toolbox addressing validation of the caregiver role, emotional\u002Fpractical support, education, communication, and navigation across health and municipal services. Involvement of the older adult in consultations is optional and based on preferences of both parties.\n\nOutcomes Feasibility outcomes include recruitment (screened\u002Feligible\u002Fconsented), retention at 12 weeks, questionnaire completeness, and deliverability (session completion, mode, duration). Acceptability will be assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief acceptability\u002Ffeasibility questions and qualitative interviews. Fidelity and tailoring will be documented using structured session notes. Exploratory outcomes include caregiver burden measured by Caregiver burden scale, quality of life measured by WHOQOL-BREF (caregiver and older adult), and physical function measured by MDHAQ .\n\nProgression criteria Pre-specified criteria include approximately 50% recruitment of those approached, ≥85% retention, and high fidelity, reviewed using a trafficlight approach (go\u002Famend\u002Fstop).\n\nEthics and dissemination Written informed consent will be obtained from both the older adult and the caregiver prior to baseline data collection, with separate consent for any study components each participant takes part in (e.g., consultations, interviews). Findings will be disseminated through peer-reviewed publication, conferences, and stakeholder summaries.",[27],"Rheumatic Arthritis",[29,30,31,32,33],"Frailty","RA","older adults","caregivers","support","RECRUITING","2026-03-16",{"date":37,"type":38},"2026-03-17","ACTUAL",{"date":40,"type":38},"2026-03-15",{"date":42,"type":21},"2027-12-01",{"name":44,"class":45},"Glostrup University Hospital, Copenhagen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100557077","effect-of-a-self-management-intervention-for-patients-newly-diagnosed-with-inflammatory-arthritis-the-nisma-trial-100557077","NCT06533423","Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial","Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: Study Protocol for a Randomized Controlled NISMA Trial","Inclusion Criteria:\n\nPatients will be included if they are adults aged 18 years or older with one of the following conditions:\n\n* Rheumatoid Arthritis (RA) with ICD-10 codes: M05.3, M05.9, M05.8, M06.9 diagnosed within the last 6 months\n* Psoriatic Arthritis (PsA) with ICD-10 codes: M073.A, M073.B diagnosed within the last 6 months\n* Axial Spondyloarthritis (axSpA) with ICD-10 codes: M45.9, M46.1, M46.8, M46.9, diagnosed within the last 12 months, and has initiated biological treatment\n\nPatients with axSpA will have unique inclusion criteria due to NSAIDs being the first-line pharmacological treatment. For those effectively treated with NSAIDs and exercise, treatment is transitioned to their general practitioner. Therefore, only those who have initiated biological treatment will be included.\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n* have insufficient language skills to discuss the topics in the intervention in Danish\n* are receiving chemo-therapy treatment for malignancies\n* are pregnant\n* have severe mental illness.","120 Years",{"count":56,"type":21},130,[24],"Background:\n\nIn patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis.\n\nMethod:\n\nThis study aims to test the efficacy of the \"Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention\" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months.\n\nPrimary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the \"skill and technique acquisition\" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline.\n\nDiscussion:\n\nThis RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.",[60],"Inflammatory Arthritis",[62,63,64,65,66,67,68],"self-management","rheumatoid arthritis","axial spondyloarthritis","psoriatic arthritis","newly diagnosed","heiQ","quality of life","2026-02-05",{"date":71,"type":38},"2026-02-09",{"date":73,"type":38},"2024-12-09",{"date":75,"type":21},"2028-05-30",{"name":44,"class":45},2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":46},"100617400","indole-3-propionic-acid-clinical-trials---multiple-sclerosis-100617400","NCT07318129","Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis","Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis (iPROACT-MS)","iPROACT-MS","Inclusion Criteria:\n\n* Women and men ≥18 and ≤65 years of age\n* Diagnosed with RRMS according to the 2017 McDonald criteria (or newer updates)\n* Routinely treated and monitored for MS\n* Speak and read Danish\n* Deemed physically and mentally able to participate in this study\n\nExclusion Criteria:\n\n* Active malignancy\n* Diagnosis of Crohn's disease and ulcerative colitis\n* Other comorbidities deemed to be relevant\n* Haematopoietic stem cell transplantation\n* Current or past treatment with non-MS related treatments deemed to be relevant\n* Pregnancy or lactation\n* People with MR contraindications:\n\n  * Severe claustrophobia\n  * Incompatible implants\u002F foreign objects, including implanted pacemakers, heart valve prostheses, prostheses in the middle ear, implanted devices (e.g., insulin pump), metal debris, e.g., metal splinters in the eyes, miscellaneous shunts and catheters, metal clips from operations","65 Years",{"count":88,"type":21},220,[24],"This study, iPROACT-MS, is part of the iPROACT group of clinical trials aiming to investigate the effects of oral supplementation with indole-3-propionic acid (IPA) in humans. IPA is naturally produced as a gut bacterial metabolite with the amino acid tryptophan as substrate. The primary aim of iPROACT-MS is to investigate whether patients with relapsing-remitting multiple sclerosis (RRMS) can benefit from supplementation with IPA. The hypothesis is that supplementation with IPA will protect against MS-related disease activity, neurodegeneration and metabolic abnormalities. Secondary, iPROACT-MS aims at elucidating the complex relationships between lifestyle, gut microbial factors, inflammation, oxidative stress, metabolic health, MS disease severity and MS disease activity.",[92],"Relapsing Remitting Multiple Sclerosis (RRMS)",[94,95,96,97,98],"indole-3-propionic acid","multiple sclerosis","gut bacterial metabolite","dietary supplement","gut-brain axis","2026-01-26",{"date":101,"type":38},"2026-01-28",{"date":99,"type":38},{"date":104,"type":21},"2028-07-15",{"name":44,"class":45},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":46},"100601055","indole-3-propionic-acid-clinical-trials---a-pilot-study-part-2-100601055","NCT07105514","Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2","Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2 (iPROACT-pilot2)","iPROACT-pilot2","Inclusion Criteria:\n\n* Healthy women and men ≥18 and ≤65 years of age\n* Deemed mentally and physically able to participate\n\nExclusion Criteria:\n\n* Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders\n* Use of antibiotics within the last month\n* Pregnancy, lactation or childbirth within the last five months\n* Use of prescription medication",true,{"count":116,"type":21},32,[24],"The goal of this trial is to investigate the biological effects of oral supplementation with indole-3-propionic acid (IPA) taken twice daily in healthy adults. The main scientific questions are:\n\n* Does supplementation with IPA increase the abundance of regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.\n* Does supplementation with IPA increase the concentration of brain-derived neurotrophic factor (BDNF) in the blood? BDNF is believed to play an important role in maintaining brain health.\n* Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases?\n\nParticipants will:\n\n* Take capsules to achieve a total daily dose of 1000 mg of IPA or placebo: 500 mg every morning and 500 mg every evening for 14 days.\n* Visit the clinic at the beginning (day 1) and at the end (day 15) of the supplementation period to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.",[120],"Healthy",[94,96,122,123,97],"regulatory T cells","brain-derived neurotrophic factor","2025-08-07",{"date":126,"type":38},"2025-08-08",{"date":128,"type":38},"2025-08-04",{"date":130,"type":21},"2026-06-30",{"name":44,"class":45},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":46},"100576986","phase-4-a-study-investigating-oral-semaglutide-in-people-with-open-angle-glaucoma-100576986","NCT06792422","A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma","Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection","ABSALON","Inclusion Criteria:\n\n* Ability to read and speak Danish\n* 45 years or older at the time of inclusion\n* Visual acuity equal to or above 0.5 in the study eye\n* Diagnosis of POAG with MD ≤ 16 dB with repeatable and reliable (false positive less than 15 %) VF loss measured by standard automated perimetry on at least one eye\n* Receiving IOP-lowering glaucoma treatment\n* Nerve fiber layer defects identified by OCT\n\nExclusion Criteria:\n\n* Diabetes or renal impairment\n* Medical history of significant eye disease (including ocular trauma) other than glaucoma\n* Ocular inflammation\u002Finfection within three months from inclusion\n* Intraocular surgery 3 months before inclusion\n* Smoker at the time of inclusion\n* Pregnant or breast-feeding\n* Females of childbearing potential who are not using adequate contraceptive, which includes the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner; Sexual abstinence\n* Subjects allergic to drug ingredients administered during the trial\n* Subjects with untreated severe systemic disease or malignancies\n* Previous history of pancreatitis\n* BMI \\\u003C 18.5\n* Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants","45 Years",{"count":142,"type":21},126,[144],"PHASE4","The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. The main question it aims to answer is: Does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram.\n\nResearchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug).\n\nParticipants will:\n\n* Take semaglutide or a placebo every day for 6 months.\n* Visit the clinic 5 times in total for tests and interviews: At baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).",[147,148,149],"Primary Open Angle Glaucoma (POAG)","Open-Angle Glaucoma","Glaucoma",[149,151,152,153,154,155,156],"Semaglutide","Rybelsus","Primary Open Angle Glaucoma","GLP-1RA","Photopic Negative Response","GLP-1","2025-01-20",{"date":159,"type":38},"2025-01-24",{"date":161,"type":21},"2025-01",{"date":163,"type":21},"2028-12",{"name":44,"class":45},""]